The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Copalis Rubella Igm.
| Device ID | K993291 |
| 510k Number | K993291 |
| Device Name: | COPALIS RUBELLA IGM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | DIASORIN, INC. 9175 GUIFORD RD. Columbia, MD 21046 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith DIASORIN, INC. 9175 GUIFORD RD. Columbia, MD 21046 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-01 |
| Decision Date | 2000-02-10 |
| Summary: | summary |